Kornimate/medical-research-clean huggingface dataset:
study of the safety, pharmacodynamics (pd) and efficacy of krn23 in children from 1 to 4 years old with x-linked hypophosphatemia (xlh)

Conditions: X-Linked Hypophosphatemia

Summary: the primary objectives of the study are to: * establish the safety profile of krn23 for the treatment of xlh in children between 1 and 4 years old * determine the pd effects of krn23 treatment on serum phosphorus and other pd markers that reflect the status of phosphate homeostasis in children between 1 and 4 years old with xlh


Eligibility criteria:
inclusion criteria: 1. male or female, aged ≥1 year and \<5 years 2. diagnosis of xlh supported by one or more of the following * confirmed phosphate regulating gene with homology to endopeptidases located on the x chromosome (phex) mutation in the patient or a directly related family member with appropriate x-linked inheritance * serum fibroblast growth factor 23 (fgf23) level \> 30 pg/ml by kainos assay 3. biochemical findings associated with xlh including: * serum phosphorus \< 3.0 mg/dl (0.97 mmol/l) * serum creatinine within age-adjusted normal range 4. radiographic evidence of rickets 5. willing to provide access to prior medical records for the collection of historical growth, biochemical, and radiographic data and disease history 6. provide written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures 7. must, in the opinion of the investigator, be willing and able to complete all aspects of the study, adhere to the study visit schedule, and comply with the assessments exclusion criteria: 1. unwilling to stop treatment with oral phosphate and/or pharmacologic vitamin d metabolite or analog (e.g. calcitriol, alfacalcidol) during the screening period and for the duration of the study 2. presence of nephrocalcinosis on renal ultrasound grade 4 based on the following scale: 0 = normal, 1 = faint hyperechogenic rim around the medullary pyramids, 2 = more intense echogenic rim with echoes faintly filling the entire pyramid, 3 = uniformly intense echoes throughout the pyramid, 4 = stone formation: solitary focus of echoes at the tip of the pyramid 3. planned or recommended orthopedic surgery including staples, 8-plates or osteotomy, within the clinical trial period 4. hypocalcemia or hypercalcemia, defined as serum calcium levels outside the age-adjusted normal limits 5. presence or history of any condition that, in the view of the investigator, places the subject at high risk of poor treatment compliance or of not completing the study 6. presence of a concurrent disease or condition that would interfere with study participation or affect safety 7. history of recurrent infection or predisposition to infection, or of known immunodeficiency 8. use of any investigational product or investigational medical device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments
randomized clinical trial of two different initial growth hormone doses in children

Conditions: Growth Disorders; Growth Failure; Growth Hormone Treatment; Growth

Summary: a prospective, randomized, open-label single-blinded study of 50 subjects with growth hormone deficiency, ages 5 to 15 years in which 25 subjects will initiate rhgh therapy at 0.3mg/kg/week and the remaining 25 subjects will initiate their rhgh treatment at 0.2 mg/kg/week for the first 12 months of treatment. safety parameters, height velocity, and adult height prediction by bone age determination will be assessed at 4-month intervals for 1 year following the initiation of rhgh therapy.

investigators propose a prospective randomized, open-label single-blinded study of 50 subjects with growth hormone deficiency, ages 5 to 15 years. 25 subjects will be randomized to initiate a dose of 0.3 mg/kg/week (0.28-0.32 mg/kg/week) and the remaining 25 subjects will initiate their rhgh treatment at 0.2 mg/kg/week (0.18-0.22 mg/kg/week) for the first 12 months of treatment. safety parameters, height velocity, and adult height prediction by bone age determination will be assessed at 4-month intervals for 1 year following the initiation of rhgh therapy.

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female, aged 5-15 years 4. in good general health as evidenced by medical history or diagnosed with growth hormone deficiency 5. ability to take subcutaneous gh injections nightly exclusion criteria: subjects will be excluded if they have gh resistance, or syndromic short stature such as prader willi syndrome and turner syndrome. patients will also be excluded if they have active malignancies, or systemic illnesses such as heart failure, kidney failure, or liver failure.

Keywords: growth hormone
let optimized impt in treating pediatric patients with ependymoma

Conditions: Anaplastic Ependymoma; Ependymoma

Summary: this phase i trial studies the side effects of linear energy transfer (let) optimized image modulated proton therapy (impt) in treating pediatric patients with ependymoma. radiation therapy such as let optimized impt, uses proton beams to kill tumor cells and shrink tumors without damaging surrounding normal tissues.

primary objectives: i. to evaluate the safety of linear energy transfer (let) optimized image modulated proton therapy (impt) (bio-impt) for pediatric patients with ependymoma. secondary objectives: i. to utilize advanced multiparametric magnetic resonance (mr) imaging to identify imaging biomarkers of structural and biological changes after proton therapy in pediatric ependymoma patients. ii. to compare quantitative image biomarkers in patients treated with bio-impt and standard proton therapy using a voxel level analysis. iii. to test and evaluate the validity of relative biological effectiveness (rbe) models and enhance their precision based on prospectively collected clinical image biomarkers. iv. to evaluate acute and late toxicities, including pseudoprogression and symptom burden, in patients treated with bio-impt. v. to estimate progression-free survival (pfs) and overall survival (os). vi. to evaluate disease outcomes following the use of a simultaneous integrated boost (sib) for pediatric ependymoma patients with gross residual disease following surgery. outline: patients receive let optimized impt for up to 6 weeks. after completion of study treatment, patients are followed up at 1 month, then every 3 months for up to 24 months.

Eligibility criteria:
inclusion criteria: * previous pathologic confirmation of ependymoma, world health organization (who) grade ii or iii * disease must be confined to the brain (no evidence of spread on mr imaging of the spine or on staging lumbar puncture) * patient may not receive chemotherapy concurrent with radiation * signed informed consent by patient and/or parents or legal guardian * lansky performance status score of 50 -100 exclusion criteria: * patients with previous radiation therapy to the brain * ependymoma of the spine * disseminated ependymoma requiring craniospinal radiation therapy * pregnancy * inability to undergo mr imaging * inability to receive gadolinium-based contrast agent
secondary obliteration of old radical cavities using s53p4 bioactive glass

Conditions: Mastoid Cavity

Summary: in canal wall down surgeries, the posterior bony wall of the external auditory canal (eac) is removed to increase exposure. the creation of a so-called radical cavity comes with several possible disadvantages, such as higher rates of postoperative otorrhea and purulence, pain, adherence to water precautions and dizziness. secondary obliteration of the mastoid cavity and reconstruction of the posterior wall of the eac can help alleviate these symptoms. our goal is to study the efficacy of secondary obliteration using s53p4 bioactive glass as obliteration material. this bioactive glass has several important characteristics, such as retaining of volume over time and antibacterial effects. the main outcome will be postoperative otorrhea as indicated by the merchant grading scale.


Eligibility criteria:
inclusion criteria: * old canal wall down cavity * operated between 2011 and 2022 exclusion criteria: * middle ear cholesteatoma * previous obliteration
effectiveness of olopatadine hcl ophthalmic solution for the treatment of allergic conjunctivitis in japan

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to evaluate the effectiveness and safety of olopatadine hydrochloride (hcl) ophthalmic solution 0.1% versus epinastine hcl ophthalmic solution, 0.05% in a population of healthy, adult japanese patients (20 years of age or older) with a history of allergic conjunctivitis to japanese cedar pollen. patients will be randomly assigned to receive olopatadine hcl ophthalmic solution, 0.1% in one eye and epinastine hcl ophthalmic solution, 0.05% in the fellow eye, after which a conjunctival allergy challenge (cac) with japanese cedar pollen will be performed.


Eligibility criteria:
inclusion criteria: * be japanese and live in japan; * history of allergic conjunctivitis; * positive skin test reaction to japanese cedar at visit 1; * positive bilateral cac reaction to the allergen at visit 1 and visit 2; * able and willing to avoid all disallowed medications during the specified period; * able to discontinue wearing contact lenses during the specified period; * sign informed consent; * other protocol-defined inclusion criteria may apply. exclusion criteria: * history of hypersensitivity to the study drug or compounds; * any ocular condition that, in the opinion of the investigator, could affect the patient's safety; * ocular surgical intervention within 3 months or refractive surgery within 6 months prior to the start of the study; * presence of active ocular infection; * use of disallowed medications as specified in the protocol; * pregnant, nursing, or planning to become pregnant during the study; * other protocol-defined exclusion criteria may apply.
evaluation of an algorithm for length based weight estimation

Conditions: Length Based Weight Estimation

Summary: the purpose of this prospective single center study is to investigate if a developed algorithm is more accurate than the pediatric emergency tape (alpha 1 werbedesign e.k., falkenberg, germany). for this study 500 patients are required to collect anonymized data (length, weight, age, anaesthesia material used during anaesthesia) for achieving a power of 80% during statistical analysis. the main hypothesis ist that the algorithm has a better accuracy than the pediatric emergency tape (53% are in a +/- 10% interval).

this prospective single center study is performed at the university children's hospital zurich. patients planned for surgery in general anaesthesia with intubation, aged 0 to 16 years and with a body length suitable for the emergency tapes can be included in this study. patient and parental information is performed during the pre-anaesthetic visit. after written consent the patient will be included. patient´s length and weight will be measures earliest one day before data collection. data collection during anaesthesia has no influence on the daily anaesthesia routine and has no impact on patient safety and anaesthesia. patient's data is made anonymous for further inspection. data is documented in microsoft excel and statistical analysis calculated with spss. 500 patients are needed for a power of 80%. primary outcome parameter is length-based weight estimation, secondary outcome parameters are length-based age estimation and the correctness of recommended anaesthesia material (endotracheal tube, laryngeal mask, oropharyngeal mask and face mask). both tools (algorithm and pediatric emergency tape) will be compared with eachother regarding primary and secondary outcome parameters.

Eligibility criteria:
inclusion criteria: * body length suitable with the investigated emergency tapes * all patients aged 0 -16 years * receiving general anaesthesia with intubation exclusion criteria: * already included in this study once * missing patient or parental consent

Keywords: broselow tape weight estimation patient safety
the efficacy of platelets rich plasma for ovarian rejuvenation

Conditions: Infertility, Female

Summary: in recent years, an increased approach has appeared in the use of autologous blood products to assist tissue and organ healing. application of platelet rich plasma (prp) has emerged as a potential solution for infertile women with poor ovarian reserve in reproductive specialty.

quantitative and qualitative functional improvement of ovarian function has been reported in several studies after using autologous prp in a reproductive field. ovarian rejuvenation, stimulating the ovaries to produce new eggs after injecting prp, can offer hope for renewed fertility to women with poor reserve volume, advanced maternal age, or either naturally occurring or premature menopause. but, these encouraging results should be supported by several new studies. this study aimed to estimate the efficacy of trans-vaginal ovarian injection with prp in rejuvenates ovaries in woman with poor ovarian reserve, and to assess any association of some women variables (age, menstrual status, parity, bmi) as predicting factors in success of ovarian injection with prp.

Eligibility criteria:
inclusion criteria: 1. menopause or peri-menopause under the age of 50. 2. premature ovarian insufficiency which is ovarian failure before the age of 40. 3. woman with primary ovarian failure of any cause. exclusion criteria: 1. a previous injection with any medication, plasma, or prp 2. invisible or difficult access ovaries. 3. medical disease or unfit for anesthesia patient.

Keywords: ovarian rejuvenation , infertility
effect of smoking cessation on glycemic control in type 2 diabetics

Conditions: Smoking Cessation

Summary: the goal of this observational study is to learn about the long-term effects of smoking cessation on glycemic control in type 2 diabetic patients the main question it aims to answer is: does smoking cessation lower hba1c in type 2 diabetics on long term ? the participants will be counseled to cessate smoking and will be followed for 6 months and compared to control who will not cessate smoking .

smoking and diabetes are both major public health issues specially in our community. they act synergistically on morbidity and mortality. diabetic smokers have much higher rates of micro and macrovascular complications. \[carole clair et al., 2020\] approximately 1.3 billion people worldwide use tobacco, most commonly in the form of tobacco smoking, and more than 7 million people die every year as a result of smoking related conditions \[magdalena walicka et al.,2022\] exposure to cigarette smoke is associated with vascular damage, endothelial dysfunction, and activation of oxidative stress, inflammatory pathways, coagulation, and fibrinolysis a similar mechanism of endothelial dysfunction is described for people with diabetes. it is therefore not surprising that smoking enhances the combined harmful effects of elevated blood glucose levels, accelerating vascular damage in diabetic patients who smoke the prevalence of current smoking was 45.5% in male patients with type 2 diabetes. the levels of fasting blood glucose and hba1c increased with number of cigarettes smoked per day compared with non-smokers smoking and its cessation showed dose- and time-dependent relationship with glycemic control and insulin resistance in patients with type 2 diabetes mellitus. these findings may highlight the importance of smoking cessation in the clinical management of diabetes mellitus. the effect of smoking and its cessation on glycemic control in diabetic patients has not been fully examined yet. there is lack of evidence regarding interventions for smoking cessation among individuals with diabetes

Eligibility criteria:
inclusion criteria: - moderate somking index having been diagnosed with a type 2 diabetes being ≥ 35 years old hba1c \> 7 exclusion criteria: type 1 diabetes drug induced diabetes mellitus type 2 diabetes on insulin treatment
bi 425809 in patients with cognitive impairment due to alzheimer's disease.

Conditions: Alzheimer Disease

Summary: the study is designed to compare the effects of bi 425809 compared to placebo in patients with cognitive impairment due to alzheimer's disease.


Eligibility criteria:
inclusion criteria: * patients with early signs of dementia of alzheimer type * male and female patients with an age of at least 55 years * concomitant use of acetylcholinesterase inhibitors (acheis) is allowed but not required. patients who are currently taking acheis are eligible as long as they have been using a stable dose for at least 3 months prior to screening and no change is foreseen for the duration of the study. this dose must be consistent with the product label in the concerned country. patients who are not currently taking acheis but have taken them in the past are also eligible if acheis were stopped at least 3 months prior to screening. * patients must have at least 6 years of formal education and fluency in the test language as verbally confirmed by the patient and documented by the study investigator. * patients must have a reliable study partner (per investigator judgement, for instance a family member, partner etc., guardian) * further inclusion criteria apply exclusion criteria: * cognitive impairment or dementia with any etiology other than alzheimer's dementia (ad) * substantial concomitant cerebrovascular disease (defined by a history of a stroke / intracranial haemorrhagia) temporally related to the onset of worsening of cognitive impairment per investigator judgement * medical history or diagnosis of any of symptomatic and unstable/uncontrolled conditions per investigator judgement * patients receiving prescribed drugs for treatment of dementia of alzheimer type (other than acetylcholine esterase inhibitors) at screening or within 3 months prior to screening * previous participation in investigational drug studies of dementia of alzheimer's type within three months prior to screening. patients having received any active treatment in studies targeting disease modification of ad are excluded. previous participation in studies with non-prescription medications, vitamins or other nutritional formulations is allowed. * clinically significant uncompensated hearing loss in the judgment of the investigator. use of hearing aids is allowed. * further exclusion criteria apply
differential intervention trial by standard therapy versus pitavastatin in patients with chronic hemodialysis (dialysis)

Conditions: Cardiovascular Disease

Summary: the purpose of this study is to verify whether pitavastatin prevents from cardiovascular events and improves the mortality in chronic hemodialysis patients with hypercholesteremia.

it was already proved by the clinical trials that statins prevent from death and cardiovascular events. however, the efficacy of statins in patients with chronic hemodialysis has not been proved yet.

Eligibility criteria:
inclusion criteria: * patients under hemodialysis * patients with hypercholesterolemia as defined by any of following parameters: * ldl-c ≧ 100 mg / dl * tc ≧ 180 mg / dl * patients required cholesterol-lowering treatment by investigators. * patients aged 20-75 years * patients with written consent by their own volition after being provided sufficient explanation for the participation into this clinical trial exclusion criteria: * patients taking statins or fibrates * patients enrolled to the other trials using contraindication drugs of pitavastatin * patients who had acute myocardial infarction within six months before the day of the agreement acquisition * patients scheduled pci and cabg within six months after the day of the agreement acquisition * patients who had diagnosis or doubt of malignant tumor * patients corresponded to "contraindications" of pitavastatin * familial hypercholesterolemia patients * patients judged ineligible by investigators

Keywords: pitavastatin hemodialysis mortality cardiovascular disease
burnout determinants among pediatric psychiatry workers during covid-19 crisis

Conditions: Burnout

Summary: burnout among health workers is at core of our current preoccupations because of the health crisis we're going trough. indeed, covid-19 epidemic had terrible consequences not only on global mental health both in adults and children, but also on health workers mental health. the investigators chose to consider pediatric psychiatry workers because of their particular position in this crisis. the aim of the study is to point out burnout determining factors among pediatric psychiatry workers in occitanie during covid-19 crisis, by the use of an online questionnaire including the copenhagen burnout inventory.


Eligibility criteria:
inclusion criteria: - medical doctors, interns, paramedics (nurse, assistant nurse), psychologists, caseworkers working \> 50% in a structure medico socio sanitaire exclusion criteria: - other persons working in a in a structure medico socio sanitaire

Keywords: burnout status
renal effects of levosimendan in cardiac surgery patients

Conditions: Treatment of Left Heart Insufficiency in an Operative Setting of Cardiac Surgery

Summary: recent experimental and clinical data suggest a benefit of levosimendan on the kidney function. therefore, this retrospective, single center, matched-pairs analysis aimed to investigate whether administration of levosimendan was associated with improved renal function in cardiac surgery patients.


Eligibility criteria:
inclusion criteria: * patients undergoing cardiac surgery (ops 5-35 bis 5-37) between 2007 and 2011 followed by postoperative observation on an icu of the anaesthesiology department of the charité hospital exclusion criteria: * patients younger 18 * preexisting renal insufficiency

Keywords: levosimendan renal effects cardiac surgery left heart insufficiency
comparative responses to 15 different antidepressants in major depressive disorder

Conditions: Major Depressive Disorder

Summary: achieving results from rcts with high internal and external validity is a major challenge within psychiatry due to the nature of psychiatric illnesses. the investigators will conduct a "real world" naturalistic nation-wide population-based longitudinal register linkage study comparing long-term responses to all kinds of antidepressants in patients with major depressive disorder emulating a randomized trial.


Eligibility criteria:
inclusion criteria: all patients with a psychiatric contact (as inpatients or outpatients) in the period from 1995 to 2018 with a first main index diagnosis of a single depressive episode or recurrent depressive disorder (icd-10 code: f32-f33.9) with an outpatient purchase of an antidepressant after the depression diagnosis (n=73.336). exclusion criteria: none.